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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Constrained, Cemented
510(k) Number K123862
FOIA Releasable 510(k) K123862
Device Name ZIMMER NEXEL TOTAL ELBOW
Applicant
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Applicant Contact JOANNA L SURMA
Correspondent
Zimmer, Inc.
1800 W. Center St.
Warsaw,  IN  46580
Correspondent Contact JOANNA L SURMA
Regulation Number888.3150
Classification Product Code
JDC  
Date Received12/14/2012
Decision Date 03/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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